Validation and Compliance Project Engineer | Life Sciences

Capgemini Engineering; Diegem; Hybride; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Hybrid work

Mentoring programs

Learning platforms access

Résumé du poste

Capgemini Engineering in Belgium is seeking a Medior Project Engineer – Validation & Compliance to coordinate validation activities within regulated pharmaceutical projects. You will liaise between Engineering and Quality Assurance to ensure safe, compliant, and efficient delivery across capital projects.

The role emphasizes GMP and ISO/ICH standards, technical writing, and ensuring traceability from planning through implementation.

Qualifications

• Master's degree in Engineering or related scientific field; equivalent experience considered.
• Minimum of 2 years in a regulated pharmaceutical or production environment with GMP understanding.
• Strong communication and stakeholder management across cross-functional teams.
• Fluent in Dutch and English with excellent technical writing and attention to detail.
• Experience with aseptic processes, cleaning, disinfection, sterilisation, or lab environments is advantageous.

Responsabilités

• Coordinate validation and verification activities across capital projects, monitoring schedules from planning to implementation.
• Interpret and apply GMP regulations (US and EU), ISO, ICH, and internal quality standards as liaison between Engineering and QA.
• Draft, review, and manage validation protocols and qualification documents with precise technical writing.
• Lead Quality Risk Assessments and support investigations related to quality issues and change control.
• Manage multiple projects, contribute to continuous improvement, support new product introductions.
• Assist qualification and validation of analytical methods and support computer-controlled systems when applicable.

Connaissances

GMP

Validation

Formation

Master's degree in Engineering

Description du poste

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life‑saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities where you can make a difference and where no two days are the same.

Your Role

We are looking for a Medior Project Engineer – Validation & Compliance to join our team in Flanders, Belgium. In this role, you will coordinate validation and verification activities within capital projects in a regulated pharmaceutical environment, acting as a key interface between Engineering and Quality Assurance to ensure safe, compliant, and efficient project delivery. In this role you will play a key role in:

• Coordinating validation and verification activities across capital projects, developing and monitoring project schedules from planning through to full implementation, ensuring all milestones are met with accuracy and compliance at the forefront.
• Interpreting and applying GMP regulations (US and EU), international standards (ISO, ICH), and internal quality standards, serving as the primary liaison between Engineering and Quality Assurance teams to maintain alignment throughout project lifecycles.
• Drafting, reviewing, and managing validation protocols, qualification documentation, and technical compliance documents, upholding the highest standards of technical writing and documentation accuracy at all times.
• Facilitating Quality Risk Assessments (QRM) and providing expertise in validation, verification, and risk management, as well as supporting investigations related to quality issues, deviations, and change‑control processes.
• Managing one or more projects simultaneously, contributing to continuous improvement initiatives, supporting the introduction of new products, and addressing urgent quality investigations with a structured and solution‑driven approach.
• Supporting qualification and validation of analytical methods and contributing to the development of computer‑controlled systems where applicable, while also providing backup support to fellow project engineers as needed.

Your Profile

• You hold a Master’s degree in Engineering (Civil, Industrial, or Bio‑engineering), Industrial Pharmacy, or a relevant scientific field such as Biochemistry, Biotechnology, or a related discipline — equivalent experience will also be considered.
• You bring a minimum of 2 years of experience in a regulated pharmaceutical or production environment, with a solid understanding of GMP requirements and validation and qualification processes.
• You demonstrate strong communication and stakeholder management skills, with the ability to collaborate effectively across cross‑functional teams, manage multiple priorities in a dynamic environment, and take ownership of your responsibilities with attention to detail and reliability.
• You are fluent in both Dutch and English, with excellent technical writing capabilities and a structured, detail‑oriented working style that ensures accuracy and quality in every deliverable.
• Experience with aseptic processes, cleaning, disinfection, sterilisation, or laboratory environments is a strong advantage and will be highly valued.

What You Will Love About Working Here

• Hybrid working – We encourage flexibility when it comes to when and where work gets done. Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.
• Mentoring programs – Capgemini empowers women at all career stages with programs spanning STEM education to career reentry. We value mentorship for fostering professional growth and empowerment within our engineering community.
• Free access to learning platforms – Free access for all to world‑class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55‑year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end‑to‑end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market‑leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.